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Tag: Federal Circuit

A patent is invalid if the invention was sold more than a year before filing (on-sale bar), and the recent “Helsinn v Teva” case shows that the courts can be harsh.

A patent applicant can accidentally ruin their own patent in various ways. In the US, one error is to first sell an invention (presumably in the form of a product), and then wait more than a year to file the patent. This error violates the 35 USC 102 on-sale bar of classic (pre-2012) patent law. This error also violates the latest 2012 AIA version of patent law, which phrases this as “on sale, or otherwise available to the public”.

However, the relationship between an “invention” and a “product” isn’t always clear, and it also isn’t always clear if a “sale” has taken place. If I privately show you a cardboard box and say “I have an invention inside, want to buy it sometime if it works?”, and you say “Maybe”, is this a sale that invalidates a later patent? In the event of doubt, how will the courts rule? Will they err on the side of protecting the patent, or invalidating the patent?

In their May 1, 2017 “Helsinn Healthcare via Teva Pharmaceuticals” decision, the Federal Circuit took a harsh and patent unfriendly approach. Indeed, this ruling was so harsh that Lamar Smith, the Congressional sponsor of the 2012 AIA law, stated that the court was ignoring the intent of Congress.

To greatly simplify the Helsinn case: back in 2001, Helsinn was doing FDA clinical trials on the efficacy of various palonosetron drug formulations to reduce nausea during chemotherapy. During these trials, they signed a supply agreement with MGI (another company) stating that if the FDA approved some of Helsinn’s various drug formulations, and if MGI subsequently made purchase orders for these drug formulations, and if Helsinn subsequently accepted these purchase orders, then Helsinn would sell the drug to MGI. In 2003, after the clinical trials were successful, but before FDA approval, and before any actual product changed hands, Helsinn began filing for various patents.

Teva, a competitor, decided to challenge these patents as being invalid due to the “on-sale bar”. But was there really a sale? Was there an invention yet? Was it disclosed to the public? A lower court ruled in favor of Helsinn, but the Federal Circuit reversed.

The Federal Circuit used the Uniform Commercial Code (UCC – a set of laws intended to “save” ambiguous contracts by automatically supplying missing terms) to argue that there was a “sale” despite all the “ifs” and ambiguity. They then argued that the invention was in the (undelivered) product and that the invention existed before clinical proof that it actually worked. Strangely, they even argued that the AIA “on sale, or otherwise available to the public” language didn’t apply because… this would change past practice. Apparently Congress, (despite good reasons and clear intent) somehow doesn’t have enough authority to make these changes?

As previously discussed, since the Supreme Court’s 2014 “Alice” decision, patent law has been burdened with an unworkable “is it abstract?” test for patent eligibility. This test is similar to a medieval test to determine witches: Step 1: “determine if the test subject is a witch abstract”; Step 2: “if so, does the witch float? is there something more?”

The Federal Circuit, charged with cleaning up patent law, has been slowly chipping away at this nonsense. In two earlier cases (Enfish and Rapid Litigation), the Federal Circuit established at least a few reasonable step 1 rules (such as read the entire claim), and now we have another.

Thales Visionix had a patent on a motion-tracking Head Mounted Display (HMD). This patent claimed a HMD arrangement of inertial sensors and signal processing elements, used in the F-35 fighter jet. Any enemy pilot blown up by this HMD system might not consider this to be “abstract”, but a lower US court was not so easily impressed. They used their own “Alice:it’s abstract” weapon to shot down the HMD patent.

In the absence of rules (the Supreme Court thoughtfully declined to provide any), lower courts have often used a type of “guilt by association” logic, where if a given patent claim has some elements in common with another claim previously ruled to be abstract, then that claim is also abstract. The lower court argued that the Thales patent claims were abstract because the claims allegedly “usedmathematical equations(previously determined to be abstract) for determining the relative position of a moving object to a moving reference frame”.

However the Federal Circuit disagreed. They determined that just because a claim contains a patent ineligible (abstract) concept (e.g. mathematical equations) does not mean that the entire claim is (step 1) “abstract.” Rather, the question is if the patent ineligible concept (math, natural law) is being used to improve some other technique. If so, then the claim as a whole is not abstract. This is similar to their earlier, more biotech-focused, ruling in the Rapid Litigation case.

So as a medieval logic analogy, just because a woman has a cat does not automatically mean that the woman is a witch, if the cat is unusually good at catching mice. If improved mouse catching can be shown, the step 1 conclusion is that the woman is not a witch. There is no need to go on and subject the poor woman to a step 2 “witch float” test. This is good, because there is a high casualty rate at step 2.

Forget “patent invalid because abstract”, the Planet Blue decision finds the real issue is preemption, and non-preemptive software claims are not abstract.

As previously discussed, in recent years the Supreme Court (SCOTUS) issued a series of confused rulings such as the “Alice” and “Mayo” decisions. SCOTUS ruled that “abstract” inventions were not patentable, but didn’t define “abstract”, thus making the issue very subjective and bringing much confusion to software and biotech patents.

Fortunately, perhaps realizing that they did more harm than good, SCOTUS has recently started to decline further cases of this type. They are apparently now leaving it to the Federal Circuit (the court right below SCOTUS) to clean things up.

Over the past few months, the Federal Circuit has initiated a number of damage control efforts, including their “Enfish”, “Bascom”, and “Rapid Litigation” decisions. Now with another case, “Mcro, Inc. v. Bandi Namco Games”, we have still more damage control. (Mcro calls itself “Planet Blue”, so we will call this the “Planet Blue” decision.)

The “Planet Blue” patent involved some improved methods of lip synchronization for animated cartoons, and their claims covered some novel but general rules to do this. A lower court had originally invalidated these as being abstract, but the Federal Circuit reversed and said that the claims were OK.

As per their earlier Enfish decision, the Federal Circuit did not simply assume that software is “abstract” (under Alice step 1). Instead, they asked the broader question, why is “abstract” a problem anyway? As they interpreted it, “The concern underlying the exceptions to § 101 is not tangibility, but preemption.” [Emphasis added]

Some history about patents and “preemption”: Back in1853 Samuel Morse, inventor of the telegraph, tried to get a claim for the use of electromagnetism for any method of printing characters or signs. However, this particular claim omitted any other details. The 1853 SCOTUS said “no”, because claims where “it matters not by what process or machinery the result is accomplished” (e.g. are preemptive) are not going to be allowed.

In Planet Blue, the Federal Circuit (possibly giving up on the more recent rulings as being hopelessly confused), has essentially gone back to the 1853 Morse case for some coherent guidance. The Federal Circuit ruled that with regards to the Planet Blue claims, “The claim uses the limited rules in a process specifically designed to achieve an improved technological result in conventional industry practice… Claim 1 of the ’576 patent, therefore, is not directed to an abstract idea.” In other words, this passes Alice “step 1”, and you get a free “get out of abstract patent eligibility rejections” card.

The big win here is that “preemption” is a more objective issue, and by changing the analysis from “abstract” to “preemption”, we remove a lot of randomness from the patent process. To me, this looks like an important ruling, and good news for software patents, biotech patents, and indeed all types of patents.

In Rapid Litigation v Cellzdirect, the Federal Circuit has further cleaned up the patent eligibility mess caused by SCOTUS’s Alice and Mayo decisions.

In 2012 and 2014, the Supreme Court (SCOTUS), which wanted to invalidate a few pesky financial and medical diagnostics patents, decided to use legal “nuclear weapons” rather than legal “fly swatters“. The SCOTUS legal nuclear weapons were the now infamous two-step “abstract material” patent eligibility test. Step 1 of this test is summarized below:

Step 1) Determine if the patent is directed to “abstract” subject material. If not then congratulations, the patent passes this test and is patent eligible.

SCOTUS refused to define “abstract material”. This allowed the USPTO and the lower courts to run amok and start randomly invalidating patents. This, in turn, started to damage US biotech and software startups, which need patents to get funding, as well as for protection from larger competitors.

The Federal Circuit, one step below SCOTUS, and charged with cleaning-up patent law, waited several years for SCOTUS to correct itself, to no avail. However, their recent (mid-2016) series of patent eligibility decisions, first Enfish, then Bascom, now Rapid Litigation(Celsis) v Cellzdirect suggest that the Federal Circuit is now getting serious about damage control.

“Abstract” is just as undefined for biotech as it is for software, but for biotech, it seems have more of a “natural law-ish” flavor. Arguably a technologically illiterate approach since everything involves natural laws, but alas SCOTUS has no STEM majors.

Fortunately, some Federal Circuit judges are STEM majors, and they have the power to do at least some damage control by providing official interpretations/clarifications of SCOTUS decisions. Here they clarified that in step 1, “directed to” is not the same thing as “involving”.

The patent in this case, 7,604,929, was about an improved method of freeze storing liver cells (cryopreservation of hepatocytes). Before the patent, everyone in the field believed that freezing damages living cells, and that multiple freeze-thaw cycles should be avoided. The inventors discovered that some hepatocytes were resistant to this problem, and used this discovery to invent an improved hepatocyte cryopreservation method. This method first freeze-thawed the cells, then used a density gradient to select for the freezing resistant cells, and then refroze these resistant cells again, producing very freeze resistant hepatocytes.

An earlier court had ruled this patent invalid by arguing that discovering that some hepatocytes could survive multiple freeze-thaw cycles involved a “law of nature”. However, the Federal Circuit pointed out that “involved” isn’t enough grounds to invalidate a patent, because the ‘929 methods also claimed other steps, such as using density gradients. So “directed to” is more than just “involves“.

This Federal Circuit decision makes it harder to invalidate biotech patents, at least in the most common cases where the claims also have other steps in addition to the “natural law” steps. The fact that the ‘929 claims were relatively simple helps to further clarify the legal issues.

The Bascom court decision helps software patents by suggesting that step 2 of the Alice test should follow established obviousness rules.

US software patents got another win from the Federal Circuit Court this week. This court, which has a Congressional mandate to clarify patent law, made an important clarification to the Alice (software patent killer) “abstract subject matter” test in the Bascom v AT&T case (Bascom).

As you may recall from our last “Enfish” episode, the Supreme Court (SCOTUS) “Alice” decision created a judge-ordered incoherent two-step test that any given patent must pass in order to be patent eligible under 35 USC 101 rules. To simplify:

Step 1) Determine if the patent is directed to “abstract” subject material. If not then congratulations, the patent passes this test.

Step 2) But if the patent is found to be “abstract” in step 1, then determine if the patent contains “something extra” beyond just “abstract” subject material. If there is nothing extra, then reject the patent as being “abstract”.

The Federal Circuit is one step down from SCOTUS. The Federal Circuit doesn’t have enough clout to overrule SCOTUS, but does have enough clout to overrule the USPTO and the lower courts. More importantly, the Federal Circuit has both the clout and mandate to “clarify” SCOTUS decisions.

The USPTO and the lower courts were often ignoring Alice step 1 and just assuming that a patent had “abstract” subject matter. The previous Federal Circuit “Enfish” decision pointed out that this was improper. By contrast, the newer Federal Circut “Bascom” case is now clarifying that another common practice, just asserting that the patent fails Alice step 2 because it lacks an undefined “something extra”, isn’t right either.

More specifically, in Bascom, the Federal Circuit pointed out that based on earlier SCOTUS decisions (e.g. Mayo v. Prometheus, which SCOTUS used for “Alice”), Alice step 2 tests if the claim is “well-understood, routine or conventional”. According to the Federal Circuit’s interpretation, SCOTUS was probably thinking about something similar to an obviousness test. The Federal Circuit also pointed out that there are well-established rules for establishing obviousness, which the USPTO and the lower courts were (also) ignoring.

Specifically, the Bascom case was an appeal of a lower court decision that had earlier found the Bascom patent claims to be “abstract” and therefore invalid. The lower court’s arguments (in simplified form) were that the Bascom patent claim language words described conventional computer pieces, and therefore the Bascom claims failed Alice step 2 due to lack of “something more”.

In Bascom, the Federal Circuit Court, after “clarifying” Alice by pointing out that SCOTUS’s Alice step 2 resembled an obviousness test, then pointed out that the lower court had failed to follow established rules to determine obviousness (35 USC 103 rules). These 35 USC 103 rules require that the combination of the pieces and the motive for combining the pieces also be considered. Here conventional pieces, arranged in a non-conventional way, are often not obvious.

The Federal Circuit then looked at the Bascom claims, determined that they were not obvious, and (again somewhat simplifying) therefore had “something more” that satisfied step 2 of the Alice test. They then overruled the lower court and found the Bascom patent to be “not abstract” and therefore valid under 35 USC 101.

If this holds up, the Bascom decision could almost bring some sanity to the Alice test. Stay tuned…

Litigation by unfair surprise is out, at least for US patent PTAB cases — for European patent oppositions, not so much.

One thing that I will never forget about my experience with European patent oppositions is that to American eyes, the European process appears to be rather “due process of law” impaired.

For example, although in theory, issues should be argued in advance by written briefs, the European opposition process also allows parties to introduce new issues during the last minute oral arguments.

This allows for litigation by “unfair surprise”, rather than by reasoned arguments. In this sort of setting, I have seen that illogical but last minute “Chewbacca defenses” can work quite well. The clock is ticking, proceedings are going to finish in an hour, and suddenly you have to discuss entirely new and logically irrelevant issues. It is as if you suddenly have to shift gears and focus on if the Star Wars character Chewbacca lives on the planet Endor or not.

In this regard, it is refreshing to see that the Federal Circuit in Dell Inc., v. Acceleron, LLC (March 15, 2016) has confirmed that this sort of litigation by unfair surprise is unacceptable for US PTAB patent reviews. Due process wins — arguments made during oral argument must be restricted to only those arguments previously discussed in writing beforehand.

In my opinion, part of the “Alice” patent problem is that few true impartial (i.e. neutral) judges have really been involved yet.

Both the USPTO and Federal judges have at least a subconscious incentive to get complex patents off of their respective desks with a minimum of time and effort. Why fill your head with complex matters — just say the patent is “abstract”, and the problem is gone. Instant relief! So perhaps there is an inherent conflict of interest built into the legal system in this regard.

So, as the Supreme Court itself warned, Alice will continue to swallow up more and more patent law until it finally reaches an opposing force. Given our legal system, this opposing force may have to be formed by group of middle to large sized companies. Here, any company that doesn’t depend on either advertising, copyrights, or non-innovative technology might be a potential candidate for such a group.

Perhaps some of the presently pending cases will eventually put some boundaries here.

35 USC 103 “obviousness” rejections: The recent Federal Circuit case of Leo Pharmaceutical Products, Ltd. v. Rea, 2013 WL 4054937 suggests that the Federal Circuit may be starting to develop a new set of criteria and arguments that can help protect against hindsight bias in obviousness rejections. In Leo, the Federal Circuit held that “to avoid the trap of hindsight”, probative evidence of nonobviousness should also be considered. What was new was that the Leo court held that this can include both evidence of long felt but unsolved needs, and the length of time between the publication dates of the prior art (used in the obviousness rejection) and the claimed invention. Specifically Leo court held that the existence of a large time gap between the prior art publications, and the invention, can also be used as indicia of non-obviousness.

How long must this time gap be? The Leo court held that given a longstanding need, if the prior art citations used in the obviousness rejection are on the order of about 14-22 years old, then this is too long. That is, such an extensive time delay is probative for non-obviousness because if the combination of such long known citations was actually obvious, then the combination would have been disclosed sooner.

An interesting consequence of this ruling is a novel (but risky) “shoot the moon” type of patent prosecution strategy for obviousness rejections. That is, Leo can be interpreted as a Federal Court suggestion to find out how far back in time the relevant citations actually extend. For example, if the prior art is actually 30 years old, but the citations used to demonstrate the prior art were only 5 years old, the following could be done:

Explore the roots of the 5 year old prior art citation

Trace back to the original 30 year old prior art

Disclose the 30 year old prior art citations

Make a Leo type argument

The logic seems sound – something known 30 years ago was also known 5 years ago. The fact that the citations were not combined until the invention, despite a long-felt need, is probative that that the combination was not obvious.

This is arguably a “shoot the moon” legal strategy (i.e. a long shot). So remember that as always, this is not legal advice, and Kids, don’t try this at home!

What is patentable? Perhaps I was too optimistic in my earlier “Prometheus bound (or at least distinguished)” post.

The May 10 Federal Circuit court decision, “CLS Bank v. Alice Corporation” shows that the Federal Circuit is unfortunately still spinning its wheels with regards to determining basic questions about what is patent eligible.

The good news is that the decision’s various logical problems, and the logical problems with the underlying Supreme Court decisions, are being widely publicized. Indeed interest in this decision was so high that the Federal Circuit Court servers crashed under the load of everyone trying to download the decision at once!

If you are interested in seeing the present state of the art in regards to cutting-edge legal confusion, you can download the Federal Circuit decision at: